PDA Journal of Pharmaceutical Science and Technology最新文献_第6页

Comparison of Binary Alcohol/Water Solvent Systems to Blood for Extractions of Blood-Contacting Medical Devices 二元醇/水溶剂系统与血液的比较，用于提取与血液接触的医疗设备的成分

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-04-25 DOI: 10.5731/pdajpst.2023.012892

M. Jordi, Taryn Meade, Kevin Rowland, Chi-hu Ho, Jordan Tocher, Weixi Liu

引用次数: 0

Applying Knowledge to Manage Risk - A Case Study in Application of the Risk Knowledge Infinity (RKI) Cycle 应用知识管理风险 - 风险知识无限循环（RKI）应用案例研究

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-04-25 DOI: 10.5731/pdajpst.2023.012931

Peer Schmidt, M. Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen, Kevin O'Donnell

引用次数: 0

Proceedings of the 2023 Viral Clearance Symposium: 2023 VCS Summary, Pending Questions, and Next Steps. 2023 年病毒清除研讨会会议记录：2023 年病毒清除研讨会总结、未决问题和下一步行动。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002240

David Roush, Glen Bolton

{"title":"Proceedings of the 2023 Viral Clearance Symposium: 2023 VCS Summary, Pending Questions, and Next Steps.","authors":"David Roush, Glen Bolton","doi":"10.5731/pdajpst.2024.002240","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002240","url":null,"abstract":"The 2023 Viral Clearance Symposium (VCS) was hosted by Takeda on 24 and 25 May 2023 in Vienna, Austria. The present conference extended the structure of the previous biennial symposia held between 2009 and 2019. As recapitulated in the introductory session, the genesis of the VCS, as described in the Proceedings of the 2009 VCS was \"the worldwide regulatory and industry recognition that challenges, gaps, and opportunities exist, that it formally addressed could benefit the field as whole.\" This report provides a synopsis of the progress achieved at the conference resulting from detailed technical discussions and the pending questions that still require attention to address. The 2023 VCS was composed of nine individual sessions of short presentations followed by in-depth panel discussions from the presenters. Sessions included Regulatory Updates (with a focus on ICH Q5A(R2) efforts), including a summary of lessons learned from the 2019 VCS, and progress on these key areas mapped into 2023 VCS topics: Viral Clearance Strategy and Case Studies, New Modalities in Chromatography and Adsorptive Filters, Continuous Processing, Viral Clearance Strategy and Process Understanding, Virus Inactivation, Upstream and Downstream Virus Retentive Filtration and Cell Banks, and Advanced Technologies (advanced therapy medicinal products, next-generation sequencing).","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"141-143"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140868933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Proceedings of the 2023 Viral Clearance Symposium, Session 3: 2023 VCS New Modalities in Chromatography and Adsorptive Filters. 2023 年病毒清除研讨会论文集，第 3 次会议：2023 年 VCS 色谱和吸附过滤器的新模式。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002243

David Roush, Glen Bolton

引用次数: 0

Proceedings of the 2023 Viral Clearance Symposium, Session 2: Viral Clearance Strategy and Case Studies. 2023 年病毒清除研讨会论文集》，会议 2：病毒清除战略与案例研究。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002242

Frank Kohne, Astrid Schwantes

{"title":"Proceedings of the 2023 Viral Clearance Symposium, Session 2: Viral Clearance Strategy and Case Studies.","authors":"Frank Kohne, Astrid Schwantes","doi":"10.5731/pdajpst.2024.002242","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002242","url":null,"abstract":"This session deals with the rational design of viral clearance studies for biopharmaceuticals including recombinant proteins such as monoclonal antibodies and, as new in scope of the symposium, also viral clearance for adeno-associated viral (AAV) vectors. For recombinant proteins, large datasets were accumulated over the last decades and are intended to be used for accelerated product process development and streamlining of viral clearance studies. How to utilize prior knowledge in viral clearance validation and how it can be used in a risk assessment tool to decide whether additional virus clearance studies are necessary during product development is being addressed by three of the presentations of this session. This also includes an a priori intended design and generation of validation data for a new kind of detergent such as CG-110, to build up a platform dataset to be used as prior knowledge in future marketing application. Another presentation investigates the virus removal mechanism of a newly developed hydrophobic interaction chromatography (HIC) resin and demonstrates for highly hydrophobic antibodies appropriate reduction for a retrovirus and impurities in a defined process range in contrast to the moderate to poor virus reduction of recent HIC resins. The last two presentations deal with virus clearance approaches for AAV, which will become mandatory with approval of the ICH Q5A revision. Appropriate virus removal and virus inactivation procedures can be implemented into the manufacturing processes of AAV vectors including viral filtration, viral inactivation (e.g., heat inactivation), affinity chromatography, and anion-exchange chromatography with which it seems possible to achieve a good clearance for helper and also adventitious viruses. The heat treatment step can be even a robust step for adenovirus helper inactivation for AAV products when product characteristics and process conditions are understood.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"147-156"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140868609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Proceedings of the 2023 Viral Clearance Symposium, Session 5: Viral Clearance Strategy and Process Understanding. 2023 年病毒清除研讨会论文集》，会议 5：病毒清除战略与流程理解。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002245

Kurt Brorson, Sean O'Donnell

引用次数: 0

Proceedings of the 2023 Viral Clearance Symposium, Session 7: Up- and Downstream Virus Retentive Filtration. 2023 年病毒清除研讨会论文集，第七场：上游和下游病毒保留过滤。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002247

Xiaoxiang Zhu, Sean O'Donnell

引用次数: 0

Proceedings of the 2023 Viral Clearance Symposium, Session 1: Regulatory Updates. 2023 年病毒清除研讨会论文集，会议 1：法规更新。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002241

Thomas R Kreil

引用次数: 0

Proceedings of the 2023 Viral Clearance Symposium, Session 6: Viral Inactivation. 2023 年病毒清除研讨会论文集，第 6 单元：病毒灭活。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002246

Junfen Ma, David Roush

{"title":"Proceedings of the 2023 Viral Clearance Symposium, Session 6: Viral Inactivation.","authors":"Junfen Ma, David Roush","doi":"10.5731/pdajpst.2024.002246","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002246","url":null,"abstract":"The use of detergents or low pH hold are commonly employed techniques in biologics downstream processing to inactivate enveloped viruses. These approaches have been demonstrated to be robust and are detailed in ASTM E2888 (low pH) and ASTM E3042-16 (Triton X-100), accordingly. One of the recent challenges is the need for a replacement of Triton X-100 with a more environmentally friendly detergent with similar log10 reduction value (LRV) achieved. The presentations in this session focused on a detailed assessment of a range of detergents. The most well characterized and potentially robust detergents identified were TDAO (n-Tetradecyl-N,N-dimethylamine-N-oxide) and Simulsol SL 11 W. Key performance factors assessed (in direct comparison with the industry standard Triton X-100) were viral inactivation kinetics (total elapsed time to achieve equilibrium), LRV achieved of enveloped viruses, toxicity, potential impact on product quality and process performance, clearance of residual detergent in subsequent downstream steps, assays to support assessment with appropriate limit of quantification, and commercial supply of detergent of the appropriate quality standard. Both TDAO and Simulsol SL11 had similar overall LRV as Triton-100. In addition, for the low pH viral inactivation, reduced LRV was observed at pH > 3.70 and low salt concentration (outside of the ASTM range), which is a cautionary note when applying low pH inactivation to labile proteins.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"187-195"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140855729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Proceedings of the 2023 Viral Clearance Symposium, Session 8: Cell Banks, Advanced Technologies (ATMPs, NGS). 2023 年病毒清除研讨会论文集》，会议 8：细胞库、先进技术（ATMP、NGS）。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002248

Johanna Kindermann, Thomas R Kreil

{"title":"Proceedings of the 2023 Viral Clearance Symposium, Session 8: Cell Banks, Advanced Technologies (ATMPs, NGS).","authors":"Johanna Kindermann, Thomas R Kreil","doi":"10.5731/pdajpst.2024.002248","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002248","url":null,"abstract":"The Cell Banks, Advanced Technologies (ATMPs, NGS) session at the 2023 Viral Clearance Symposium (VCS) focused on the assurance of high virus safety profiles of advanced technology medicinal products (ATMPs) by implementation of advanced virus detection methods using rapid and sensitive technologies, such as next-generation sequencing (NGS). All presentations in this session made the need to replace in vivo testing for viruses by new technologies that have been demonstrated to be incomparably broad in their detection capabilities and can even detect unknown viruses. An evaluation of historical data collected by the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) from their members' in vivo and in vitro adventitious virus test experience as well as on using NGS was presented. The data convincingly supported the necessity to replace in vivo testing with faster, broader, more sensitive, more accurate, and more specific virus detection methods. Additionally, a collaborative study-initiated by the CAACB-with the goal to revisit traditional adventitious agent testing by using targeted NGS to replace in vivo and in vitro tests for well-known and broadly used Chinese hamster ovary (CHO) cells was presented, including the planned risk-assessment approach using prior knowledge and historical data. Overall, this session demonstrated that the use of new virus detection methods, such as NGS, represents a great opportunity to provide sufficient viral safety margins, specifically, for ATMPs, where downstream virus clearance is not possible. This path forward is also supported by the final ICH Q5A(R2) guideline.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"206-211"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140864697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0